Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Zachary Pohlkamp

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Betablockers, Antihypertensives, Sympathetic meds

Disqualifiers: Cardiovascular disease, Diabetes, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Varies

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spinal cord stimulation can manage blood pressure changes and improve immune and heart function in people with spinal cord injuries. It tests two types of stimulation: epidural (applied near the spinal cord) and transcutaneous (through the skin). Participants with spinal cord injuries between the C6 and T8 levels, who experienced their injury over six months ago, may be suitable candidates. The trial also includes a control group of people without spinal cord injuries for comparison. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for spinal cord injuries.

Will I have to stop taking my current medications?

If you are taking betablockers, antihypertensives, or other medications that affect the sympathetic nervous system and cannot stop them, you cannot participate in the trial. The protocol does not specify a washout period, but you should discuss your medications with the trial team.

What prior data suggests that these stimulation techniques are safe for spinal cord injury patients?

Research has shown that both epidural and transcutaneous stimulations have been studied for safety in people with spinal cord injuries.

For epidural stimulation, studies have found it generally safe, similar to its use in treating chronic pain. It is usually well-tolerated, with no new safety concerns for people with spinal cord injuries.

Regarding transcutaneous stimulation, research indicates it is safe and practical for people with chronic spinal cord injuries. One study found that combining it with activity-based therapy, such as physical exercises, was safe for participants.

Both treatments have shown promising results in previous research, with no major safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a new way to help people with spinal cord injuries regain function. Unlike traditional therapies that focus on physical rehabilitation and medications to manage symptoms, epidural stimulation involves implanting a device that sends electrical signals directly to the spinal cord. This can potentially reactivate nerve circuits and improve movement. Transcutaneous stimulation, on the other hand, is non-invasive and uses electrodes placed on the skin to stimulate the spinal cord, offering a less invasive option with the potential for significant benefits. Both methods aim to enhance recovery and quality of life for individuals with spinal cord injuries, which is why they are generating so much interest.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

This trial will compare two different spinal cord stimulation methods for individuals with spinal cord injuries. Participants in one arm will receive epidural stimulation, which studies have shown can greatly improve movement. In one study, 44% of patients using this method were able to stand or walk with assistance, and 87% had better muscle control. Another study found that some patients could stand and support their weight without help.

Participants in the other arm will receive transcutaneous stimulation. Research on this method also shows promising results. In one study, 72% of participants achieved their main goals for better movement. Another study found that this method improved balance, stability, and leg function, making everyday activities easier. Both treatments offer hope for helping those with spinal cord injuries regain some physical abilities. ^{4 5 6 7 8}

Who Is on the Research Team?

Ryan Solinsky, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injury. It's designed to understand how their bodies manage blood pressure changes and the impact of spinal cord stimulation on these processes, as well as immune and cardiovascular functions.

Inclusion Criteria

Time since injury of greater than six months

Both individuals with and without currently implanted epidural spinal cord stimulators will be enrolled

I am between 18 and 50 years old.

Exclusion Criteria

My BMI is over 30 and I am an uninjured control participant.

In the judgement of the principal investigator, any illness or condition that will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results

I am taking medication that may not mix well with phenylephrine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laboratory Diagnostic Testing

Participants undergo various diagnostic tests including Valsalva maneuver, ECG, blood pressure monitoring, and blood draws to assess cardiovascular and immune function.

1 session

1 visit (in-person)

Treatment

Participants receive either transcutaneous or epidural spinal cord stimulation to assess its effects on blood pressure and cardiovascular function.

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epidural stimulation
• Transcutaneous stimulation

Trial Overview The study tests various forms of spinal cord stimulation: transcutaneous, epidural, and testing sympathetic activation both below and above the level of injury. The goal is to observe effects on blood pressure regulation and other bodily functions.

How Is the Trial Designed?

Group I: Transcutaneous stimulation Experimental Treatment 4 Interventions

Individuals with spinal cord injury receiving transcutaneous stimulation

Group II: Epidural stimulation Experimental Treatment 4 Interventions

Individuals with spinal cord injury receiving epidural stimulation

Group III: Control Experimental Treatment 3 Interventions

Control participants without a spinal cord injury

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9297213/

Effect of epidural spinal cord stimulation after chronic spinal ... The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function.

2. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

3. spj.science.org spj.science.org/doi/10.34133/cbsystems.0314

Epidural Electrical Stimulation for Functional Recovery in ... This study confirms the promising therapeutic effects of EES in SCI. EES combined with PT provides a potential approach for functional recovery in patients ...

4. mdpi.com mdpi.com/2077-0383/13/4/1090

Epidural Spinal Cord Stimulation for Spinal Cord Injury in ... Results indicated significant improvements in motor function: 44% of patients achieved assisted or independent stepping or standing; 87% showed enhanced muscle ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2025.2517935?src=

Spinal epidural electrical stimulation for the recovery of ... With epidural stimulation, four subjects gained better control of standing full weight bearing (without assistance). Four (80%) subjects were ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35701485/

The safety of epidural spinal cord stimulation to restore ... Conclusions: eSCS to restore autonomic and volitional motor function following SCI has a similar safety profile as when used to treat chronic pain, despite the ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07042815

Long-term Follow-up for Epidural Stimulation in SCI The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury. The main aims are to: provide ...

8. nature.com nature.com/articles/s41467-023-37845-7

A case study of percutaneous epidural stimulation to ... The safety of epidural spinal cord stimulation to restore function after spinal cord injury: post-surgical complications and incidence of ...